U.S. Food and Drug Administration
Protecting and Promoting Your Health
Submitting a Meeting Request
Details for requesting a formal meeting with CDER is outlined in FDA's Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants.
Information in a meeting request should include:
- Product name
- Application number (if applicable)
- Chemical name and structure
- Proposed indication(s) or context of product development
- Type of meeting being requested
- Note: Type A meeting requests must include the rationale and a meeting package
Click NEXT to continue.
